MAUDE Adverse Event Report: TELEFLEX MEDICAL POL GN BR 4-0 ME-2 2N 18"; SUTURE, NONABSORBABLE, SYNTHET

Model Number	IPN914473
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).No issues or discrepancies were found in the device history record of product code 6-692/batch 74d1903046 that can be related to the failure mode reported.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The needle broke in half during suturing of the tissue.The patient's condition was reported as fine, no complications.The broken needle became lodged in the periosteum and soft tissue of the lateral orbital rim.It was retrieved after performing additional dissection.
Additional Manufacturer Narrative
Qn(b)(4).Only a portion of the suture was received with only 1 needle attached at one end and cut at 8 inches.Additionally, the needle shows signs of manipulation, marks and contamination was detected throughout the needle.The suture was dimensionally inspected, suture specification is 18" long however during the dimensional inspection, the suture was found to be 8".5long.No other testing was performed to the suture due the conditions in which the samples arrived.Incoming inspection records of the needle lot involved in the manufacturing of product code 6-692 / batch 74d1903046 were reviewed, no issues or discrepancies were found.Per ifu l06824 rev.01 for polyester surgical suture - statement for precautions - in handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps of needle holder.Adequate knot security requires the accepted surgical technique of flat, square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.Based in the findings during visual and dimensional inspection, customer complaint cannot be confirmed since the defect found is not related to a manufacturing issue but most likely a consequence of interaction with a non-teleflex device.No issues or discrepancies were found in the device history record of product code 6-692 / batch 74d1903046 that can be related to the failure mode reported.Based in the findings during visual and dimensional inspection, customer complaint cannot be confirmed since the defect found is not related to a manufacturing issue but most likely a consequence of interaction with a non-teleflex device.Manufacturing personnel will be notified of this event for awareness.
Event or Problem Description
The needle broke in half during suturing of the tissue.The patient's condition was reported as fine, no complications.The broken needle became lodged in the periosteum and soft tissue of the lateral orbital rim.It was retrieved after performing additional dissection.

• Brand Name: POL GN BR 4-0 ME-2 2N 18"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHET
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11655706
• Report Number: 3004365956-2021-00159
• Device Sequence Number: 14332750
• Product Code: GAT
• UDI-Device Identifier: 14026704716293
• UDI-Public: 14026704716293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: IPN914473
• Device Catalogue Number: 6-692
• Device Lot Number: 74D1903046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention